Catalog Number

011-AM3090

Brand Name

ICU Medical

Version/Model Number

011-AM3090

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K964435,K964435

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

d20d205b-3499-4c8a-8afa-1403ac98389b

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

10840619091726

Quantity per Package

50

Contains DI Package

00840619091729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS